Use of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma

Study Purpose

This is a multicenter, single arm, open-label, Phase 2 study in high risk smoldering myeloma patients. The primary objective is to determine the efficacy of Elranatamab in patients with previously untreated high-risk SMM. The key-secondary objective is to determine the safety of Elranatamab in patients with previously untreated high-risk SMM.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. >18 years of age. 2. Diagnosis of SMM for ≤5 years with measurable disease, defined as serum M protein: ≥1g/dL or urine M protein ≥200 mg/24 hours or involved serum FLC ≥100 mg/Land abnormal serum FLC ratio. 3. BMPCs ≥10% and <60% 4. Presence of at least 2 high risk factors, including. 1. Serum M protein ≥2 g/dL, 2. BMPC >20% 3. Serum involved/uninvolved FLC ratio > 20. 5. ECOG performance status score of 0 or 1. 6. Subjects must meet the following laboratory parameters, per laboratory reference range (performed at most 15 days before cycle 1 day 1) 1. Absolute neutrophil count ≥1.0 x 109/L (ie, ≥1000/μL) 2. Platelet count ≥75 x 109/L. 3. Aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN) 4. Alanine aminotransferase (ALT) ≤2.5 x ULN. 5. Total bilirubin ≤1.5 x ULN, except in subjects with congenital bilirubinemia,such as Gilbert syndrome (in which case direct bilirubin ≤2.0 x ULN is required) 7. Subject must sign an informed consent form (ICF) or their legally acceptable representative must sign indicating that he or she understands the purpose of, and procedures required for the study and is willing to participate in the study. 8. Women of childbearing potential must have a negative serum or urine pregnancy test at screening and before starting study drug. They must commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control (One highly effective method and one additional effective method) used at the same time, and continuing for at least 5 months after the last dose of Elranatamab. Women must also agree to notify pregnancy during the study.

Exclusion Criteria:

1. Previous therapy with any systemic therapy for multiple myeloma. 2. Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): 1. Increased calcium levels: Corrected serum calcium >1 mg/dL above the ULN or >11 mg/dL. 2. Renal insufficiency: Determined by glomerular filtration rate (GFR) <40 mL/min/1.73 m² (Modification of Diet in Renal Disease [MDRD] Formula) or serum creatinine >2 mg/dL. 3. Anemia (hemoglobin 2 g/dL below lower limit of normal or <10 g/dL or both) transfusion support or concurrent treatment with erythropoietin stimulating agents is not permitted. 4. ≥ 1 bone lytic lesion. 5. BMPCs ≥60% 6. Serum involved/uninvolved FLC ratio ≥100 and an involved FLC ≥100mg/L. 7. Whole body magnetic resonance imaging (WB-MRI) or positron emission tomography-computed tomography (PET-CT) with more than 1 bone focal lesion (≥5 mm in diameter) 3. Diagnosis of primary amyloidosis, POEMS syndrome, monoclonal gammopathy of undetermined significance, symptomatic multiple myeloma, or solitary plasmacytoma. 4. Subject has a diagnosis of Waldenström's macroglobulinemia, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions. 5. Subject has had plasmapheresis within 14 days of elegibility confirmation. 6. Myocardial infarction within 6 months prior to enrolment according to NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. 7. Ongoing Grade 2 or higher peripheral sensory/motor peripheral neuropathy (PN), history of GBS or GBS variants, or history of grade 3 or higher peripheral motor polyneuropathy. 8. Subject has had major surgery within 2 weeks before elegibility confirmation or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study. 9. Clinically relevant active infection or serious co-morbid medical conditions. 10. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer free of disease since 5 years. 11. Female subject who is pregnant or breast-feeding. 12. Serious medical or psychiatric illness likely to interfere with participation in study. 13. Uncontrolled diabetes mellitus. 14. Known HIV infection; Known active hepatitis B or C viral infection; known active COVID-19/SARS-CoV-2 infection. 15. Live attenuated vaccine administered within 4 weeks of the first dose of study intervention. 16. Ongoing treatment with corticosteroids : dose >10mg prednisone etc. 17. Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06183489
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Stichting European Myeloma Network
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Not yet recruiting
Countries Finland, France, Greece, Italy, Netherlands, Norway
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Smoldering Multiple Myeloma
Arms & Interventions

Arms

Experimental: Elranatamab

Participant will receive elranatamab subcutaneously (SC) for 24 cycles (28-day cycle)

Interventions

Drug: - Elranatamab

Elranatamab will be administered via a subcutaneous injection (SC)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Helsinki University Hospital, Helsinki, Finland

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Helsinki University Hospital

Helsinki, ,

CHD Vendée, La Roche-sur-Yon, France

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CHD Vendée

La Roche-sur-Yon, ,

CHRU de Lille - Hopital Claude Huriez, Lille, France

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CHRU de Lille - Hopital Claude Huriez

Lille, ,

Montpellier, France

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CHU Saint Eloi Département d'Hématologie Clinique

Montpellier, ,

Nantes, France

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CHU Hôtel-Dieu, 1, place Alexis Ricordeau, 44093 NANTES Cedex 1, FRANCE

Nantes, ,

CHU NICE - Hôpital Archet, Nice, France

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CHU NICE - Hôpital Archet

Nice, ,

Poitiers, France

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CHU Poitiers - Pôle régional de Cancérologie

Poitiers, ,

CHRU Hôpital Bretonneau, Tours, France

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CHRU Hôpital Bretonneau

Tours, ,

Athens, Greece

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Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens

Athens, ,

AOU Consorziale Policlinico di Bari, Bari, Italy

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AOU Consorziale Policlinico di Bari

Bari, ,

A.O. Papa Giovanni XXIII, Bergamo, Italy

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A.O. Papa Giovanni XXIII

Bergamo, ,

A.O.U. Careggi, Firenze, Italy

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A.O.U. Careggi

Firenze, ,

Genova, Italy

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A.O.U. Policlinico S. Martino - Ematologia

Genova, ,

Meldola, Italy

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Meldola-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)

Meldola, ,

Ospedale Papardo, Messina, Italy

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Ospedale Papardo

Messina, ,

A.O.U. Maggiore della Carità Novara, Novara, Italy

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A.O.U. Maggiore della Carità Novara

Novara, ,

A.O. di Padova, Padova, Italy

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A.O. di Padova

Padova, ,

A.O.U. di Parma - U.O Ematologia e CTMO, Parma, Italy

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A.O.U. di Parma - U.O Ematologia e CTMO

Parma, ,

Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy

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Fondazione IRCCS Policlinico S. Matteo

Pavia, ,

Ospedale Santo Spirito, Roma, Italy

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Ospedale Santo Spirito

Roma, ,

Udine, Italy

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Clinica Ematologica Azienda Sanitaria Universitaria Friuli Centrale

Udine, ,

Maastricht UMC, Maastricht, Netherlands

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Maastricht UMC

Maastricht, ,

St. Antonius Ziekenhuis, Nieuwegein, Netherlands

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St. Antonius Ziekenhuis

Nieuwegein, ,

Erasmus MC, Rotterdam, Netherlands

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Erasmus MC

Rotterdam, ,

Oslo Myeloma Center, Oslo, Norway

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Oslo Myeloma Center

Oslo, , 0450